Remdesivir vs. Hydroxychloroquine

Medical Monopoly Musings #44
Remdesivir – Poor Science and Conflicts of Interest

Remdesivir is an intravenous anti-viral drug being used for the novel coronavirus. It is produced by Gilead Sciences.

Pharmaceutical companies tend to have very high profit margins. When more than 10% profit is considered good…Gilead had over 50% profits in 2015 on $32.6 billion dollars!

With the novel coronavirus, the drugs companies have been rushing to cash in (*ahem* save lives).

The NIAID study showed that those patients with COVID19 taking remdesivir improved in recovery time and discharge from the hospital, down from 15 days to 11 days. However, the survival difference between remdesivir patients and placebo control was not statistically significant (8% vs. 11.6%).

(Meanwhile, a Chinese study published earlier at the end of April did not find any statistically significant clinical improvement. Here 14% of remdesivir patients died while 13% on placebo did, though again, not statistically significant.)

Christopher Roland of the Washington Post wrote, “Fauci said the results were modest. But, lacking any other treatments, he proclaimed the drug the "standard of care" for hospitalized coronavirus patients. Full results of the trial have not been released, and many questions about the drug's effectiveness remain unanswered.”

The standard of care based on a press release and an interview. On May 1st the FDA issued emergency use authorization for remdesivir for treating COVID-19.

Over three weeks later, on May 22nd, the full study and data was finally released. Turns out the results for faster recovery time were only for a sub-group, those also receiving supplementary oxygen. Furthermore, they also changed the primary outcome during the trial from number of deaths to recovery time while the trials were ongoing (though those who changed it said they didn’t have access to the data).

The study concludes, “These preliminary findings support the use of remdesivir for patients who are hospitalized with Covid-19 and require supplemental oxygen therapy. However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.”

At the time of writing there are numerous other clinical trials with remdesivir in progress.

Early on, Gilead pledged to donate 1.5 million doses of the drug. Beyond that, an independent organization estimated that Gilead could be charging up $4500 per patient for the drug…on something that is estimated to cost $1 per dose. What is $4500 more when that average coronavirus hospital bill is $30,000, especially since few patients are paying out of pocket?

So at best the drug has a modest effect. At worst, it has some negative side effects that was dropping people out of the trials. But wait, there’s more…

As I’ve established over the course of this series, conflicts of interest are often at the root of controversies of the medical monopoly. Here is no different.

Investigative journalist Sharyl Attkisson said, “When it comes to money, we checked financial ties among experts on the government panel devising coronavirus treatment guidelines— which had the effect of dialing back hydroxychloroquine use and giving an edge to remdesivir. We found that of 11 members reporting links to a drug company, nine of them named relationships to remdesivir’s maker Gilead. Seven more, including two of the committee’s leaders, have ties to Gilead beyond the 11 months they had to disclose. Two were on Gilead’s advisory board. Others were paid consultants or received research support and honoraria.”

There are other conflicts, but Gilead is by far the leader. Isn’t it interesting that the only approved drug happens to come from this company? Just a coincidence, right?

To give perspective on how conflicts of interest work on government panels we can look at the criminal case of Vioxx and similar drugs. The FDA’s 2005 advisory board had 32 advisors, ten of which had conflicts of interest with the drugs’ maker Merck. The board voted to keep these dangerous drugs on the market, but had these conflicted members not been involved, the vote would have gone the other way. Eight of these ten said that their ties did not alter their votes. (At least two were honest about it!)

Next time, we’ll turn to the even more controversial hydroxychloroquine, which is off patent and very cheap in comparison. Never has science become so politicized with a media barrage involved…

References:
https://www.macrotrends.net/stocks/charts/GILD/gilead-sciences/profit-margins
https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext
https://www.businessinsider.com/coronavirus-treatment-icer-pricing-analysis-on-gileads-remdesivir-2020-5
https://clinicaltrials.gov/ct2/results?cond=COVID-19&term=remdesivir&cntry=&state=&city=&dist=&Search=Search
https://www.chron.com/business/article/Taxpayers-paid-to-develop-remdesivir-but-will-15296173.php
https://www.cnbc.com/2020/04/09/heres-what-you-need-to-know-about-coronavirus-treatment-costs.html
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
https://www.zerohedge.com/technology/remdesivir-study-finally-out-drug-only-helped-those-oxygen-finds-mortality-too-high
http://fullmeasure.news/news/cover-story/hydroxychloroquine
https://www.covid19treatmentguidelines.nih.gov/panel-financial-disclosure/
https://www.nytimes.com/2005/02/25/politics/10-voters-on-panel-backing-pain-pills-had-industry-ties.html

*****

Medical Monopoly Musings #45
Hydroxychloroquine – Poor Science and Conflicts of Interest

Last time we covered the drug Remdesivir for COVID-19 and how this was bound to conflicts of interest with the drug’s maker Gilead in the approving committee, as well as some questionable science on whether it worked. Now we turn to hydroxychloroquine (HCQ), which was notably promoted by President Trump.

In this case, we’ll cover the drug in the same way as the previous one, looking at science and conflicts of interest.

The crazy thing is it is not possible to have this conversation in a balanced way anymore as politics is more polarized than ever. Personally, I am critical of lots of Trump’s actions and words, but unlike many, I am not blinded by 100% hatred for the man. There are some things he does and says that I do agree with.

Trump was not the first one to talk about HCQ. This was recommended by scientists across the world first and foremost by French Dr. Didier Raoult who said, “We know how to cure the disease.”

One study touted by the media in the USA was done at the VA showed that more people died when taking HCQ. But there were flaws in this study. As a retrospective study, it wasn’t randomized. More importantly sicker patients were put into the treatment group, which would then make sense as to why they died more.

An influential study was published in the Lancet showing HCQ increased mortality which seemed to be the death-knell for this drug, so much so that the WHO paused its other ongoing trials of the drug (which were later resumed). This led many to claim that Trump’s disinformation was killing people!

Yet, this study was later retracted when the company behind the data, Surgisphere, wouldn’t share said data. They were behind another NEJ M paper that got retracted for the same reason, though this one looked at ACE inhibitors, not HCQ.

Looking deeper, these are the only studies this company’s data has been used for. According to LinkedIn they only had five employees. Checking at the time of writing this, the number has gone down to two. Prior to February of this year the company only had one employee, the founder Dr. Desai, who has had malpractice suits against him.

(Part 2) The URL for the company has been excluded from the Internet Archive Wayback Machine. This is highly unusual, in fact, I have never seen any site disappear from it before!

There is much more controversy behind this company and its founder which you can find in the references. In other words, Surgisphere appears to be a shell company whose sole aims appeared to be to make HCQ look bad. So who was behind it?

One thing we find is that the Lancet paper’s lead author, Dr. Mandeep Mehra has a long list of drug and medical company conflicts. He has “personal fees from Abbott, Medtronic, Janssen, Mesoblast, Portola, Bayer, Baim Institute for Clinical Research, NupulseCV, FineHeart, Leviticus, Roivant, and Triple Gene.” This study was “supported” by Brigham and Women’s Hospital where they’re also doing Remdesivir studies with over 1,000 patients, for which they’re receiving funding from Gilead.

Yes, there are still more studies that show no benefit. Many of these don’t use zinc which is said to open the cellular pathway to allow HCQ into the cells to work. Dr. Anthony Cardillo said “[HCQ] really only works in conjunction with zinc. Every patient I have prescribed it to has been very, very ill and within eight to twelve hours they were basically symptom-free and so clinically I am seeing a resolution.”

Importantly, there are many studies that DO show benefit with little to no risk. A public Google document titled, “Sequential CQ / HCQ Research Papers and Reports January to April 20, 2020: Executive Summary Interpretation of the Data In This Report” shows more than 20 trials from across the world. They state, “The HCQ-AZ combination [an antibiotic also used in combination], when started immediately after diagnosis, appears to be a safe and efficient treatment for COVID-19, with a mortality rate of 0.5%, in elderly patients. It avoids worsening and clears virus persistence and contagious infectivity in most cases.” Doctors across the world are saying it does work.

(Part 3) What about Trump’s conflict of interest for HCQ? A big hubbub was made of this. New York Times reported, “Mr. Trump himself has a small personal financial interest in Sanofi, the French drugmaker that makes Plaquenil, the brand-name version of hydroxychloroquine…As of last year, Mr. Trump reported that his three family trusts each had investments in a Dodge & Cox mutual fund, whose largest holding was in Sanofi.”

Mutual funds own lots of stocks. For this reason mutual funds are exempt from conflict of interest laws (not that that makes it impossible for them to be a problem). Yet his stake in Sanofi is no more than $1,500. More importantly, HCQ is off-patent. While Sanofi makes it, so do many other companies. And its dirt cheap, especially compared to the new patented Remdesivir.

Meanwhile all of the New York Times articles I’ve seen have been silent regarding the conflicts of interest behind the approval of Remdesivir.

This is how “science” is done in our modern world. While most of the time bad science hides in the shadows, this is one of the most blatant examples I’ve seen! Too bad our news cycle has moved on, so the people aren’t thinking about this anymore. Few and far between will hear this story. Remdesivir is still the standard of care being promoted.

Yet, some are fighting back. The Association of American Physicians & Surgeons has sued the FDA, Health & Human Services and BARDA over this to “to end the irrational interference.”

One more personal thought…it’s all misdirection!

(Part 4) What is the drug that will save us? Notice how the entire scientific, political, and medical conversation is on this drug, that drug, or the vaccines. Notice how nothing is mentioned about ANY of the important aspects of health. I’m not saying we shouldn’t be doing drug trials and find those that can help. That’s all well and good, but if it really were about health and saving people we’d be talking about much else.

There are plenty of trials showing common nutrients are working for this disease; zinc, vitamin C, vitamin D, phytonutrients, etc. Even Google is censoring those topics as the CEO of YouTube said they will “remove information that is problematic, including anything that is medically unsubstantiated, such as take vitamin C, take turmeric. Anything that would go against WHO guidelines, we will be taking those down.”

References:
https://www.cnn.com/2020/04/21/health/hydroxychloroquine-veterans-study/index.html
https://www.sciencedirect.com/science/article/pii/S2666634020300064
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext
https://www.nejm.org/doi/full/10.1056/NEJMc2021225
https://www.medicineuncensored.com/a-study-out-of-thin-air
https://www.linkedin.com/company/surgisphere/people/
https://web.archive.org/web/*/https://surgisphere.com/
https://www.statnews.com/2020/06/03/who-resuming-hydroxychloroquine-study-for-covid-19/
https://www.theguardian.com/world/2020/jun/03/covid-19-surgisphere-who-world-health-organization-hydroxychloroquine
https://www.brighamhealthonamission.org/2020/03/26/two-remdesivir-clinical-trials-underway-at-brigham-and-womens-hospital/
https://uncoverdc.com/2020/06/06/politicized-science-lancet-nejm-retract/
https://clinicaltrials.gov/ct2/show/NCT04292899?id=NCT04292899&draw=2&rank=1
https://www.youtube.com/watch?v=Jfkz5kIH7Jg
https://www.politifact.com/factchecks/2020/apr/09/facebook-posts/trump-has-tiny-financial-stake-company-manufacture/
https://www.nytimes.com/2020/04/29/health/gilead-remdesivir-coronavirus.html
https://www.nytimes.com/2020/05/01/health/coronavirus-remdesivir.html
https://aapsonline.org/judicial/aaps-v-fda-hcq-6-2-2020.pdf
https://www.youtube.com/watch?v=YsLKs8kye7k

*****

As science goes more research is being done. There is good, legitimate research. And then there is agenda-driven research. Here’s some new data I didn’t cover before on the latter.

On June 15th, the FDA revoked emergency use authorization of HCQ and CQ. “FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”

So let’s look at some of the agenda driven science.

To of the main ones are the WHO’s Solidarity trials and the UK’s Recovery trial.

The problem is that these trials are using excessive, deadly doses. The WHO’s own information shows this. A 1979 paper by consultant H. Weniger mentions that 1.5 to 2 grams of HCQ may be fatal. Around this amount is what is being used, the Recovery trial specifically 2.4 grams in the first day.

Meanwhile, French doctor Raoult was using 600mg daily for up to ten days with his patients. Of 1061 Covid19 patients all over 74 years old, only 8 died, a mortality rate of 0.75%.

Meryl Nass, MD says “Excessive, dangerous HCQ dosing continues to be used in WHO’s Solidarity trials. These trials are not, in fact, testing the benefits of HCQ on Covid-19, but rather are testing whether patients survive toxic, non-therapeutic doses.” If you want more detail see this article here.

Only when this information was repeatedly pointed out was the HCQ arm of the trial stopped. They did it without announcing this information.

So let’s think about this for a second. Do you think these were honest mistakes? It was just an accident to use massive doses of a drug that has been widely used for decades safely at lower doses out of the blue?

Or do you think that they set out to prove the HCQ did not work, so that Gilead could make money off of Remdesivir now, and that a vaccine later on becomes the savior?

As you might expect by this point, the Gates Foundation is implicated in this research, along with the Wellcome Trust for funding the Recovery trial. As for the WHO trial, well Gates is now the #1 financial backer of the WHO.

Understand what this means:

They were not only ALLOWING people to die from COVID19 due to poorly treated them.

But they were in fact KILLING people by purposefully overdosing them on drugs all to prove this drug doesn’t work so that their agendas move forward.

References:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
https://www.recoverytrial.net/files/recovery-protocol-v6-0-2020-05-14.pdf
https://apps.who.int/iris/bitstream/handle/10665/65773/WHO_MAL_79.906.pdf?sequence=1&isAllowed=y
https://www.sciencedirect.com/science/article/pii/S1477893920302179?via%3Dihub
https://www.ageofautism.com/2020/06/who-solidarity-and-uk-recovery-clinical-trials-of-hydroxychloroquine-using-potentially-fatal-doses.html 
https://www.recoverytrial.net/files/recovery-protocol-v7-0-2020-06-18.pdf